BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADYM

    MDR report key: 3201119 · Received June 28, 2013

    Report

    Report Number
    1000165971-2013-00326
    Event Type
    Death
    Date Received
    June 28, 2013
    Date of Event
    February 27, 2013
    Report Date
    June 14, 2013
    Manufacturer
    SORIN GROUP ITALIA S.R.L.
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    THE SUBJECT ICD DELIVERED A SHOCK WHILE THE PT WAS UNDERGOING A MEDICAL PROCEDURE (COLOSCOPY). REPORTEDLY, THE SHOCK OCCURRED AFTER CARDIAC ARREST (CPR WAS PERFORMED). CONSEQUENTLY, THE PT REMAINED 3 MINUTES IN VENTRICULAR ARRHYTHMIA BEFORE THE ICD DELIVERED A SHOCK, AS REPORTED. IT REMAINS UNCLEAR WHETHER A MAGNET HAS BEEN APPLIED OR NOT. THE PT DIED (B)(6) 2013 (CEREBRAL DEATH), ALLEGEDLY BECAUSE OF THE REPORTED LONG V ARRHYTHMIA EPISODE. A DETAILED ANALYSIS OF THE EPISODE WAS REQUESTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296895 PARADYM MRM SORIN GROUP ITALIA S.R.L. PARADYM RF DR 9550 2634

    Patients

    Seq Age Sex Outcome Treatment
    1 Death